Daytime Severe Cold And Flu Capsule, Liquid Filled (acetaminophen 325mg, Guaifenesin 200mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)
de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg
Purpose
Pain reliever/ fever reducer Cough suppressant Expectorant Nasal decongestant
Medication Information
Purpose
Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg
Uses
- temporarily relieves common cold/flu symptoms:
ο nasal congestion
ο sinus congestion & pressure
ο cough due to minor throat & bronchial irritation
ο minor aches & pains
ο headache
ο fever
ο sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings:
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
| adults & children 12 years of age and over | 2 softgels with water every 4 hours |
| Children under 12 years of age | ask a doctor |
When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Overdose Warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information:
- store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients
polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water
Stop Use and Ask A Doctor If
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Principal Display Panel Shipping Label
Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-015-
EXP DATE:
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.
Structured Label Content
Uses
- temporarily relieves common cold/flu symptoms:
ο nasal congestion
ο sinus congestion & pressure
ο cough due to minor throat & bronchial irritation
ο minor aches & pains
ο headache
ο fever
ο sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Purpose
Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Warnings:
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
| adults & children 12 years of age and over | 2 softgels with water every 4 hours |
| Children under 12 years of age | ask a doctor |
When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Overdose Warning: (Overdose warning:)
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information:
- store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)
polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)
Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-015-
EXP DATE:
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.
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Source: dailymed · Ingested: 2026-02-15T11:59:26.374033 · Updated: 2026-03-14T22:59:24.470306